for the assessment of capacities at the HUMAN-ANIMAL interfacehandbook

INTERNATIONAL HEALTH REGULATIONS (2005) IHR MONITORING AND EVALUATION FRAMEWORK

for the assessment of capacities at the HUMAN-ANIMAL interface

handbook

second edition related to

the Joint external evaluation tool

international health regulations (2005)

INTERNATIONAL HEALTH REGULATIONS (2005) IHR MONITORING AND EVALUATION FRAMEWORK

for the assessment of capacities at the HUMAN-ANIMAL interface

handbook

Handbook for the assessment of capacities at the human–animal interface, second edition ISBN 978-92-4-151188-9

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Table of ConTenTs

CONTEXT ... 5

OBJECTIVE OF THE HANDBOOK ... 6

CONTENT OF THE HANDBOOK ... 6

HOw TO usE THE HANDBOOK ... 8

TABlE OF COrrEspONDENCE BETwEEN THE TECHNICAl ArEAs IN THE JEET AND THE CrITICAl CApACITIEs CArDs IN THE OIE pATHwAy TOOls ... 10

QuEsTIONs IN THE JOINT EXTErNAl EVAluATION TOOl AND AssOCIATED CrITICAl COMpETENCIEs IN THE pVs rEpOrTs PREVENT 1: NATIONAL LEGISLATION, POLICY AND FINANCING ... 11

PREVENT 2: IHR COORDINATION, COMMUNICATION AND ADVOCACY ... 14

PREVENT 3: ANTIMICROBIAL RESISTANCE (AMR) ... 15

PREVENT 4: ZOONOTIC DISEASES ... 17

PREVENT 5: FOOD SAVETY ... 20

PREVENT 6: BIOSAFETY AND BIOSECURITY ... 22

PREVENT 7: IMMUNIZATION ... 23

DETECT 1: NATIONAL LABORATORY SYSTEM ... 24

DETECT 2: REAL TIME SURVEILLANCE ... 26

DETECT 3: REPORTING ... 28

DETECT 4: WORKFORCE DEVELOPMENT ... 30

RESPONSE 1: PREPAREDNESS ... 32

RESPONSE 2: EMERGENCY RESPONSE OPERATIONS ... 34

RESPONSE 3: LINKING PUBLIC HEALTH AND SECURITY AUTHORITIES ... 36

RESPONSE 5: RISK COMMUNICATION ... 37

ANNEX 1. Key obligations associated with the IHr (2005) for which the veterinary services contribute ... 40

ANNEX 2. list of pVs Critical Competencies to be considered in the IHr Monitoring Framework ... 41

ANNEX 3. Description of the OIE pVs pathway ... 42

1 - Certain States Parties that are not Members States of WHO may become a party to the IHR by notifying acceptance of the Regulations to the Director- General of the World Health Organisation. Currently, 196 States Parties to the IHR (2005) include all WHO Member States (194) as well as the Holy See and Liechtenstein.

2 - Annex 1 of the IHR (2005) includes 2 sections: A - Core capacity requirements for surveillance and Response, and B - Core capacity requirements for designated airports, ports and ground crossing. available at www.who.int/ihr/9789241596664/en/

3 - www.who.int/ihr/publications/WHO_HSE_GCR_2016_2/en/

4 - In this manual, the terms “Veterinary Authorities” and “Veterinary Services” refer to the definitions in the OIE Code

- Veterinary Authority means the governmental authority, comprising veterinarian, other professionals and paraprofessionals, having the responsibility and competence for ensuring or supervising the implementation of animal health and welfare measures, international veterinary certification and other standards and recommendations in the OIE terrestrial Code in the whole territory.

- “Veterinary Services” means the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the Code in the territory. The veterinary Services are under the overall control and direction of the Veterinary Authority. Private sector organisations, veterinarians, veterinary paraprofessionals are normally accredited or approved by the Veterinary Authority to deliver the delegated functions.

5 - This document is the version 2 of the Handbook for the Assessment of Capacities at the Human-Animal Interface. Version 1 was associated with the IHR questionnaire used by IHR National Focal Points for their annual report to the WHA. This questionnaire is not used anymore since 2016.

ConTexT

With the coming into force of the revised International Health Regulations (IHR (2005)), all States Parties

¹

are required to assess the ability of their national structure and resources to meet minimum national core capacities for surveillance and response as specified in Annex 1 of the IHR (2005)

²

, and to develop a plan of action to ensure that these capacities be present and functioning throughout their territories.

Annex 1 of the IHR (2005) provides a list of core capacities – the capacity to detect, report, assess and respond to Public Health Event(s) of International Concern (PHEIC) - expected at the three levels of implementation in countries – central, intermediate and community levels. All States Parties have committed to report their level of compliance with IHR Annex 1 to the World Health Assembly (WHA) on a yearly basis.

In order to assist States Parties in their assessment, WHO and partners have developed an external evaluation (Joint External Evaluation, JEE) process and a tool (the JEET

³

). The first stage of the evaluation is a survey completed by the country using self-reported data for the various indicators on the JEET. A joint external evaluation team comprised of national and international subject matter experts then visit the country for facilitated in-depth discussions. As a result a draft report identifies status levels for a set of indicators, as well as an analysis of the country’s capabilities, gaps, opportunities and challenges.

When it comes to the specific contribution from Veterinary Authorities in reaching the objectives of the IHR (2005), the OIE’s Performance of Veterinary Services (PVS) Pathway assesses the performance of the national Veterinary Services and their compliance with OIE international standards on the quality of Veterinary Services. All aspects relevant to the OIE Terrestrial Animal Health Code and the quality of Veterinary Services, as per OIE definition

⁴

, are reviewed by using the PVS Pathway tools. The PVS Expert Team collects and analyses baseline information against 47 Critical Competencies, each of which are described in a specific card (Critical Competency Card). More details on PVS Pathway tools can be found in Annex 3.

PVS Pathway reports can greatly facilitate the work of the JEE, both for the self-review and for the evaluation by the JEE external team, by providing concrete information regarding the national Veterinary Services’

contribution to specific core capacities defined in the IHR (2005). This input may be obvious for some specific hazards (zoonoses, food safety, antimicrobial resistance). However there are other key areas that should also be considered for a more thorough and holistic review of strengths and gaps. This Handbook

⁵

has been developed to facilitate this exercise; it explains the synergies and complementarities between the two the JEE and the OIE PVS Pathway, with specific information including on how to use the data contained in a PVS Evaluation report to assist in the implementation of the JEE.

"Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations (…), the capacity to detect, assess, notify and report events in accordance with these Regulations… and ...the capacity to respond promptly and effectively…"

IHR (2005), Articles 5 and 13

obJeCTIVe of THe HanDbooK

Human and animal health systems communicating and collaborating together in synergy and complementarity has been largely advocated by the OIE and WHO. The two organisations have taken this principle on board and work together to advocate for their Member Countries to take advantage of existing frameworks and benefit from coordinated actions to prevent the spread of animal diseases of high impact for public health.

The development of different yet synergistic tools is a prime example of such effort.

The objective of the Handbook is to facilitate the assessment of core capacities by taking into consideration and stock of the national Veterinary Services’ contribution to a country’s compliance to the IHR (2005). Use and reference to the outputs of PVS Pathway missions will reinforce the Joint External Evaluation process by using the results of the assessments of the Veterinary Services and underscore core capacities which require constant and structured collaboration between human and animal health systems.

ConTenT of THe HanDbooK

This Handbook identifies the several areas in which the indicators in the JEET match, overlap and synergize with the Critical Competencies used in the PVS Pathway missions. The JEET is organised through 19 technical areas, classified around 4 thematic areas.

Thematic area 1 - Prevent Thematic area 3 - Respond:

- National Legislation, Policy and Financing

- IHR Coordination, Communication and Advocacy - Antimicrobial Resistance (AMR

- Zoonotic Disease - Food Safety

- Biosafety and Biosecurity - Immunization

- Preparedness

- Emergency Response Operations

- Linking Public Health and Security Authorities - Medical Countermeasures and Personnel

Deployment

- Risk Communication

Thematic area 2 - Detect: Thematic area 4 - Other IHR-related hazards - National Laboratory System

- Real Time Surveillance - Reporting

- Workforce Development

- Points of Entry (PoE) - Chemical Events - Radiation Emergencies

Every technical area is informed by one or several indicator(s) with attributes that reflect various levels of capacity with scores of 1-5 (1 indicates that implementation has not occurred; 5 indicates that implementation has occurred, is tested/reviewed/exercised and that the country has a high level of capability for the indicator). Technical Questions are proposed to facilitate the determination of the appropriate score.

Figure 1 illustrates the structure of the JEET, using one of the two indicators for the technical area National

Legislation, Policy and Financing.

Indicator P.1.2: The State can demonstrate that it has adjusted and aligned its domestic legislation, policies and administrative arrangements to enable compliance with the IHR (2005)

Technical questions:

• P.1.2.1. Does (an) assessment identify adjustment needs for relevant legislation, regulation, administrative requirements and other government instruments for IHR (2005) implementation?

• P.1.2.2. Is there evidence of using relevant legislation and policies in various sectors involved in the implementation of IHR?

• P.1.2.4. How does the country ensure coordination of the legal and regulatory frameworks between sectors?

Figure 1: One of the 2 indicators for National Legislation, Policy and Financing (Technical Area 1 / Prevent 1, Indicator N° P.1.2.) in the JEET and the first technical questions associated.

There are 48 indicators in the JEET, divided into the 19 technical areas. This handbook helps JEE users easily locate for each of the indicators the possible contribution of the national Veterinary Services by guiding them to the relevant PVS Critical Competency Card(s)

⁶

.

No Capacity – 1

Legislation, regulation, administrative requirements and other government instruments are not in place for the implementation of the IHR (2005)

Limited Capacity – 2

Assessment of relevant legislation, regulation, administrative requirements and other government instruments for IHR (2005) implementation has been carried out and adjustment needs have been identified.

Developed Capacity – 3

The country can demonstrate the existence and use of relevant laws and policies in the various sectors involved in the implementation of the IHR.

Demonstrated Capacity – 4

The country has legislation references and/or administrative requirements for specific areas (e.g. current legislation specifically address IHR NFP designation and operations).

Sustainable

Capacity – 5 The country ensures coordination of the legal and regulatory frameworks between sectors

6 - In this version of the Handbook, the technical areas on PoE, chemical and radiation emergencies have not been considered. As a result, 16 technical areas informed by 42 indicators are explored.

HoW To Use THIs HanDbooK

The definition and the area covered by the PVS Critical Competency Cards are provided below the JEET indicator being considered, with specific references to the areas of interest. Where appropriate, a short paragraph has been provided below the question describing or making explicit the contribution of the national Veterinary Services to the implementation of that technical area. Figure 2 illustrates the structure of these tables.

7 - OIE Terrestrial Animal Health Code: Articles 3.2.8 on Animal Health controls and Articles 3.2.9. on Veterinary Public Health controls.

InDICaTors In THe JeeT

P.1.2 The State can demonstrate that it has adjusted and aligned its domestic legislation, policies and administrative arrangements to enable compliance with the IHR (2005)

Comments: The veterinary services (VS) have an active role in the development of the legal and regulatory framework for the prevention and control of animal diseases including zoonosis, food safety, medicines, and several other areas under their mandate⁷.The main issues to consider here are i) the involvement of the VS in the review of the existing legal, and the regulatory and administrative instruments covering the core functions defined in the IHR (2005), ii) the description of the synergic, overlapping or possible conflicting areas between the legal, regulatory and administrative frameworks developed in the human and animal sectors for the core functions defined in the IHR (2005).

PVs CrITICal ComPeTenCy DesCrIPTIon

IV-1. Preparation of legislation and regulations This CC reviews the authority and capability of the veterinary services (VS) to actively participate in the preparation of national legislation and regulations in domains that are under their mandate, in order to guarantee its quality with respect to principles of legal drafting and legal issues and its accessibility, acceptability, and technical, social and economic applicability. This competency involves collaboration with relevant authorities, including other ministries and competent authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas.

The CC reviews inter alia:

- The legislative and regulatory framework of the veterinary domain and the mandate of the Veterinary Authority;

- The coordination of VS with relevant authorities on developing legislation and regulations regarding areas of joint or shared responsibility;

- The evidence that national legislation identifies VS roles and responsibilities related to activities where there is shared authority with other competent authorities.

Figure 2: Illustration of the tables included in this handbook, using the indicator in Figure 1 and one of the associated PVS Critical competency card.

In total, the Handbook identifies the contributions of the Veterinary Services in 35 indicators of 16 JEET

technical areas, with additional information extracted from 35 PVS Critical Competencies. Table 1 below

summarizes the relationship between the indicators from the JEET and the PVS Tool Critical Competencies.

Table 1: T able of cor respondence between the technical areas in the JEET and the Critical Capacities cards in the OIE P athway tools

PVS Critical Competency cards

I-1-A I-1-B I-2-A I-2-B I-3

I-6-A I-6-B I-7 I-8 I-9 I-11

II-1-A II-1-B II-2 II-3 II-4 II-5-A II-5-B II-6 II-7 II-8-A II-8-B II-8-C II-9

II-10 II-12-B III-1 III-2 III-3 III-5-A III-6 IV-1 IV-2 IV-3 IV-6 IV-6

PREVENT Prevent 1XXXXXXXX Prevent 2XXXX Prevent 3XXXX Prevent 4XXXXXXXXXXXXXXX Prevent 5XXXXXX Prevent 6XXXX Prevent 7 DETECT Detect 1XXX Detect 2XXXXX Detect 3XXXXXX Detect 4XXXXXXX RESPONSE Response 1XXXXXX Response 2XX Response 3XX Response 4 Response 5XXXXXXX

H O W T O A CCESS THE REPOR TS The PVS Pathwa y repor ts ar e the pr oper ty of the countr y concerned. A number of countries ha ve waiv ed the confidentiality of their PVS Pathwa y repor ts, authorizing the OIE to shar e their PVS Pathwa y repor t with par tner organizations and donors. In ad dition, some countries ha ve authorized the OIE to mak e their PVS Pathwa y r epor ts full y public; these can be vie w ed on the OIE w ebsite: - for the PVS Evaluation r epor ts: under www .oie .int/en/suppor t-to-oie-members/pvs-e valuations/oie-pvs-e valuation-r epor ts/ - for the Ga p Anal ysis r epor ts: under www .oie .int/en/suppor t-to-oie-members/pvs-ga p-anal ysis/pvs-ga p-anal ysis-r epor ts/

PREVENT 1: NA TIONAL LEGISL ATION, POLICY AND FINANCING States Par ties need to ha ve an adequate legal frame w ork to suppor t and enable implementation of the IHR (2005). This ma y requir e that the y adopt implementing or enabling legislation

8

for some or all of their obligations and rights. It can also facilitate coor dination among the diff er ent entities in volv ed in implementation. In ad dition, policies, which identify national structur es and r esponsibilities ar e also impor tant.

8 - http://www.who.int/ihr/legal_issues/legislation/en/index.html. In the context of IHR, the term "legislation, regulations and policy" is referring to the broad range of legal, administrative or other governmental instruments, whether legally binding or non-binding, and which may be available for States Parties to implement the IHR (2005). 9 - OIE Terrestrial Animal Health Code: Articles 3.2.8 on Animal Health controls and Articles 3.2.9. on Veterinary Public Health controls

In DIC aT ors In TH e J ee T - P re Ven T 1: na TI onal le GI sl aTI on , P ol IC y an D fI nan CI n G

P.1.1 Legislation, laws, regulations, administrative requirements, policies or other government instruments in place are sufficient for implementation of IHR. Key areas considered in this indicator: - Assessment of legislation, regulation and administrative requirements; - National policies to facilitate the functions of the National Focal Point. Comments: The veterinary services (VS) have an active role in the development of the legal and regulatory framework for the prevention and control of animal diseases including zoonosis, food safety, medicines, and several other areas under their mandate9. The main issues to consider here are i) the involvement of the VS in the review of the existing laws, and the regulatory and administrative instruments covering the core functions defined in the IHR (2005), ii) the description of the synergic, overlapping or possible conflicting areas between the legal, regulatory and administrative frameworks developed in the human and animal sectors for the core functions defined in the IHR (2005). Regarding the support to the IHR National Focal Point (NFP): The IHR NFP is in charge of disseminating information to, and consolidating input from relevant government sectors of the administration, reporting to WHO events which may constitute a PHEIC and reporting on the strengthening of national Core Capacities as defined in the IHR Monitoring and Evaluation Framework. The main issues to consider here are i) the existence of coordination between the VS and the IHR NFP including a good understanding by the VS of the role and obligations of the IHR NFP, ii) the communication channels and policies enabling the VS to provide expected information to the IHR NF including on the operational capacities as defined in the IHR (2005).

QU es TI ons In TH e J o In T ex Ternal e Val Ua TI on T ool an D asso CI aT eD C rITIC al C om Pe Ten CI es In TH e PV s re Por Ts PV s critical competency (cc) Description

IV-1. Preparation of legislation and regulationsThis CC reviews the authority and capability of the veterinary services (VS) to actively participate in the preparation of national legislation and regulations in domains that are under their mandate, in order to guarantee its quality with respect to principles of legal drafting and legal issues and its accessibility, acceptability, and technical, social and economic applicability. This competency involves collaboration with relevant authorities, including other ministries and competent authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas. The CC reviews inter alia: - The legislative and regulatory framework of the veterinary domain and the mandate of the Veterinary Authority; - The coordination of VS with relevant authorities on developing legislation and regulations regarding areas of joint or shared responsibility; - The evidence that national legislation identifies VS roles and responsibilities related to activities where there is shared authority with other competent authorities. IV-2. Implementation of legislation and regulations and compliance thereofThis CC reviews the authority and capability of the VS to ensure compliance with legislation and regulations under the VS mandate. The CC reviews inter alia: - The capacity of the VS to take legal action - The formal agreement and standard procedures for collaboration with other relevant authorities.

PV s critical competency (cc) Description

I-6. Coordination capability of the Veterinary Services B. External Coordination

This CC reviews the capability of the VS to coordinate its resources and activities at all levels with other relevant authorities as appropriate, in order to implement all national activities relevant for OIE Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). Relevant autho- rities include other ministries and competent authorities, national agencies and decentralised institutions. This includes inter alia - Coordination mechanisms with other authorities on area of joint responsibility; - Description of joint committee between VS and public health sector.

In DIC aT ors In TH e J ee T - P re Ven T 1: na TI onal le GI sl aTI on , P ol IC y an D fI nan CI n G

P.1.2 The State can demonstrate that it has adjusted and aligned its domestic legislation, policies and administrative arrangements to enable compliance with the IHR (2005). Key areas considered in this indicator: - Implementation of legislation, policies and administrative instrument in the various sectors involved in the implementation of IHR (2005); - Adjustment of legislation, regulation and administrative instrument toward coherence between sectors. Comments: The veterinary services (VS) have an active role in the development of the legal and regulatory framework for the prevention and control of animal diseases including zoonosis, food safety, medicines, and several other areas under their mandate10. The main issues to consider here are i) the implementation of existing legal, regulatory and administrative instruments covering the core functions defined in the IHR (2005), including for activities of early detection, reporting and response, ii) the adjustment of these instrument when required, including toward harmonization with other sectors active in the core functions defined in the IHR (2005).

PV s critical competency (cc) Description

IV-3. International harmonisationThis CC reviews the authority and capability of the VS to be active in the international harmonisation of regulations and sanitary measures and to ensure that the national legislation under their mandate take account of relevant international standards, as appropriate. The CC reviews inter alia: - The legislative framework giving to VS the authority for international or regional harmonisation activities - Procedures for reviewing legislation and effective harmonisation. IV-1. Preparation of legislation and regulationsThis CC reviews the authority and capability of the veterinary services (VS) to actively participate in the preparation of national legislation and regulations in domains that are under their mandate, in order to guarantee its quality with respect to principles of legal drafting and legal issues and its accessibility, acceptability, and technical, social and economic applicability. This competency involves collaboration with relevant authorities, including other ministries and competent authorities, national agencies and decentralised institutions that share authority or have mutual interest in relevant areas. The CC reviews inter alia: - The legislative and regulatory framework of the veterinary domain and the mandate of the Veterinary Authority; - The coordination of VS with relevant authorities on developing legislation and regulations regarding areas of joint or shared responsibility; - The evidence that national legislation identifies VS roles and responsibilities related to activities where there is shared authority with other competent authorities. IV-2.Implementation of legislation and regulations and compliance thereofThis CC reviews the authority and capability of the VS to ensure compliance with legislation and regulations under the VS mandate. This includes inter alia: - The capacity of the VS to take legal action - The formal agreement and standard procedures for collaboration with other relevant authorities. I-6. Coordination capability of the Veterinary Services B. External Coordination

This CC reviews the capability of the VS to coordinate its resources and activities at all levels with other relevant authorities as appropriate, in order to implement all national activities relevant for OIE Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). Relevant autho- rities include other ministries and competent authorities, national agencies and decentralised institutions. This includes inter alia: - Coordination mechanisms with other authorities on area of joint responsibility; - Description of joint committee between VS and public health sector. 10 - OIE Terrestrial Animal Health Code: Articles 3.2.8 on Animal Health controls and Articles 3.2.9. on Veterinary Public Health controls

PV s critical competency (cc) Description

II-7. Disease prevention, control and eradication A. Passive epidemiological surveillance

This CC reviews the authority and capability of the VS to actively perform actions to prevent, control or eradicate OIE listed diseases and/or to demonstrate that the country or a zone are free of relevant diseases. The CC considers inter alia: - The legislative framework, chain of command, and regulations for the surveillance and the control of animal and zoonotic diseases; - Procedures and/or protocols on roles and responsibilities of different parties (VS and other Competent Authorities). II-5. Epidemiological surveillance and early warning 7 pt

These CC review the authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations, including wildlife, under their mandate. The CC consider inter alia: - List of diseases, including zoonosis, on the territory; - Network of human and physical resources for surveillance; - Contacts in other agencies on relevant areas (e.g. food safety; zoonoses, emerging diseases, wildlife) and procedures for sharing relevant surveillance information; - Knowledge of OIE standard on surveillance, including reporting duties on suspicions and confirmed cases. II-6. Emergency responseThis CC reviews the authority and capability of the VS to response rapidly to a sanitary emergency (such as a significant disease outbreak or a food safety emergency). The CC considers inter alia: - The legal framework supporting the rapid responses to sanitary emergencies - The chain of command and the regulatory framework including in the collaboration with relevant authorities.

In DIC aT ors In TH e J ee T - P re Ven T 2: IH r C oor DI na TI on , C omm Un IC aTI on an D a D Vo C aC y

P.2.1 A functional mechanism is established for the coordination and integration of relevant sectors in the implementation of IHR Key areas considered in this indicator: - The existence, functioning and performance of a multisectoral coordination structure; - The coordination around the IHR National Focal Point. The IHR NFP is in charge of disseminating information to, and consolidating input from relevant government sectors of the administration, reporting to WHO events which may constitute a PHEIC and reporting on the strengthening of national Core Capacities as defined in the IHR Monitoring and Evaluation Framework. The main issues to consider here are i) the existence of coordination between the VS and the IHR NFP including a good understanding by the VS of the role and obligations of the IHR NFP, ii) the communication channels and policies enabling/restricting the VS to provide expected information to the IHR NF including on the operational capacities as defined in the IHR (2005), iii) the existence of an intersectoral coordination mechanisms (committee, taskforce, …) for the, promotion, advocacy and implementation of the IHR (2005), and more particularly for specific needs at the human-animal interface, and thye participation of the VS in this mechanism.

PV s critical competency (cc) Description

I-6. Coordination capability of the Veterinary Services B. External coordination

This CC reviews the capability of the VS to coordinate its resources and activities at all levels with other relevant authorities as appropriate, in order to implement all national activities relevant for OIE Codes (i.e. surveillance, disease control and eradication, food safety and early detection and rapid response programmes). This includes inter alia: - Coordination mechanisms with other authorities on area of joint responsibility; - Procedures and agreements with relevant competent authorities (may include those responsible for human health, security, customs, wildlife…). III-2. Consultation with interested partiesThis CC reviews the capability of the VS to consult effectively with interested parties on VS activities and programmes, and on developments in animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and competent authorities, national agencies and decentralised institutions that share authorities or have mutual interest in relevant areas. This includes inter alia: - Procedure for formal consultation with interested parties; - Establishment of inter-institutional committees. III-6. Participation of producers and other interested parties in joint programmes

This CC reviews the capability of the VS and producers and interested parties to formulate and implement joint programmes in regard to animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and competent authorities, national agencies and decentralised institutions that share authorities or have mutual interest in relevant areas. The CC explores inter alia: - Evidence of active involvement of producers and interested parties in the development, organization and delivery of programmes. III-1. CommunicationsThis CC reviews the capability of the VS to keep interested parties informed, in a transparent, effective and timely manner, of VS activities and programmes, and of deve- lopments in animal health and food safety. This competency includes collaboration with relevant authorities, including other ministries and Competent Authorities. The CC explores inter alia: - The infrastructure and the mechanisms and supports for communication with interested parties.

PREVENT 2: IHR COORDINA TION, COMMUNICA TION AND AD VOCA CY Coor dination of nationwide resour ces, including the sustaina ble functioning of a National IHR Focal Point (NFP), is a ke y requisite f or IHR (2005) implementation. The NFP should be accessible at all times to comm unicate with the WHO IHR Regional Contact Points and with all r ele vant sectors and other stak eholders in the countr y. A mechanism f or m ultisectoral/m ultidisciplinar y coor dination, comm unication and par tnerships should be functional.

In DIC aT ors In TH e J ee T - P re Ven T 3: an TI m IC rob Ial res Is Tan C e

P.3.1 Antimicrobial resistance (AMR) detection Key areas considered in this indicator: - The existence of a national plan developed jointly by the human health and the animal health sectors - Designated laboratories in both sectors. The Global Action Plan on Antimicrobial Resistance (AMR) was adopted in 2015 by all countries through decisions in the World Health Assembly, the FAO Governing Conference and the World Assembly of OIE Delegates. Countries agreed to have a national action plan on AMR that is consistent with the Global Action Plan, and to implement relevant policies and activities to prevent, control and monitor AMR. This includes developing technical capacities to detect and monitor AMR in the animal sector.

In DIC aT ors In TH e J ee T - P re Ven T 3: an TI m IC rob Ial res Is Tan C e

P.3.2 Surveillance of infections caused by AMR pathogens Key areas considered in this indicator: - A plan defining sentinel sites for the surveillance of infections caused by AMR - The on-going surveillance programmes. Surveillance and monitoring studies are conducted in many countries in both human and veterinary medicine. Since the use of antimicrobial agents is considered a driving force in the development and spread of antimicrobial resistance, studies have also been conducted to determine consumption figures of antimicrobial agents in human and veterinary medicine in various countries.

PV s critical competency (cc) Description

II-10. Residue testing This CC reviews the capability of the VS to undertake residue testing programmes for veterinary medicines (e.g. antimicrobials and hormones), chemicals, pesticides, radio- nuclides, metals, etc. This includes inter alia: - The regulatory framework and the national standards on AMR control and testing; - The official programmes on AMR control and results; - The access to an AMR testing laboratory with adequate competency and resources; - Evidence of action taken based on results from AMR testing programme, including the collaborative actions with other Competent Authorities. II-2. Laboratory quality assuranceThis CC reviews the quality of laboratories (that conduct diagnostic testing or analysis for chemical residues, antimicrobial residues, toxins, or tests for, biological efficacy, etc.) as measured by the use of formal QA systems and participation in relevant proficiency testing programmes. This includes inter alia: - Documented procedures; - Evidence of proficiency testing programmes: - Feedback from laboratories on sample submission processes; - Evidence that laboratory diagnostic procedures are in line with OIE standards.

PV s critical competency (cc) Description

II-10. Residue testingThis CC reviews the capability of the VS to undertake residue testing programmes for veterinary medicines (e.g. antimicrobials and hormones), chemicals, pesticides, radio- nuclides, metals, etc. This includes inter alia: - The regulatory framework and the national standards on AMR control and testing; - The official programmes on AMR control and results.

PREVENT 3: ANTIMICROBIAL RESIST ANCE (AMR) With the coor dinated suppor t fr om WHO , F A O , and OIE, countries ar e encouraged to a) De velop a national compr ehensiv e plan to combat antimicr obial r esistance; b) Str engthen sur veillance and laborator y ca pacity at the national le vel in both the human health and the animal health sectors and; c) Contribute to the impr ov ed conser vation of existing tr eatments and suppor t the sustaina ble de velopment of ne w antibiotics, alternativ e tr eatments, pr ev entiv e measur es and ra pid, point-of-car e diagnostics, including systems to pr eser ve ne w antibiotics.

In DIC aT ors In TH e J ee T - P re Ven T 2: IH r C oor DI na TI on , C omm Un IC aTI on an D a D Vo C aC y

P.3.3 Healthcare associate infection (HCAI) prevention and control programmes Key areas considered in this indicator: - Infection Prevention and control (IPC) for healthcare workers. No particular contribution from the Veterinary Sector

In DIC aT ors In TH e J ee T - P re Ven T 2: IH r C oor DI na TI on , C omm Un IC aTI on an D a D Vo C aC y

P.3.4 Antimicrobial stewardship activities Key areas considered in this indicator: - Appropriate use of antimicrobial; - Rules in prescription and delivery Access to and responsible and prudent use of antimicrobial agents for animals must be regulated and monitored by well-trained veterinarians, whose ethics are ensured by a Veterinary Statutory Body.

PV s critical competency (cc) Description

II-9. Veterinary medicines and biologicalsThis CC reviews the authority and capability of the VS to regulate veterinary medicines and veterinary biologicals in order to ensure their responsible and prudent use i.e. the marketing, authorisation , registration, import, manufacture, quality control, export, labelling, advertising, distribution, sale and use of these products. This includes inter alia: - List of medicines and biological products authorised and registered; - Inspections, procedures for pharmacovigilance. III-5. Veterinary Statutory Body (VSB) A. VSB authorityThe VBS is an autonomous authority responsible for the regulation of the veterinarians and veterinarian para-professionals. Its role is defined in the OIE Terrestrial Code. This includes inter alia: - Regulation of functions and application of disciplinary measures.

In DIC aT ors In TH e J ee T - P re Ven T 4: Z oono TIC DI seases

P.4.1 Surveillance systems in place for priority zoonotic diseases/pathogens Key areas considered in this indicator: - The priorization of zoonotic diseases of relevance for the country; - The existence of specific surveillance systems for zoonotic diseases of importance (including in wildlife) in animal health, human health and collaboration; - The sharing of data; - The functional link between public health laboratories and animal health laboratories. The VS conduct passive and active surveillance for animal diseases including zoonosis and report at the national level in compliance with OIE standards. Passive surveillance supposes that appropriate field networks for the detection of the disease events, collection of samples and submission for laboratory diagnosis of suspect cases are in place. Stakeholders’ involvement and compliance with their obligation to report the suspicion and occurrence of notifiable diseases to the VS is also assessed in the PVS. Active surveillance presupposes a list of priority diseases, collection of data on susceptible (sub)populations on which the surveil- lance is applied, protocols and quality assessment of the programmes, collaboration with stakeholders. Diagnostic capacities to assure a reliable and timely identification of the agent and mechanisms to facilitate coordination for the exchange of expertise, resources and data between the laboratories are critical. Each OIE Member Country must report the occurrence of animal diseases, the emergence of new diseases and significant epidemiological events within 24 hours of the event. This also includes diseases transmis- sible to humans and the deliberate introduction of pathogens.

PV s critical competency (cc) Description

II-7. Disease prevention, control and eradication This CC reviews the authority and capability of the VS to actively perform actions to prevent, control or eradicate OIE listed diseases and/or to demonstrate that the country or a zone are free of relevant diseases. The CC considers inter alia: - The list of disease of epizootic or zoonotic importance - The prevention, control and eradication programmes to be conducted in collaboration with other relevant parties; - The procedures and/or protocols on roles and responsibilities of different parties (VS and other Competent Authorities). II-5. Epidemiological surveillance and early warning A. Passive epidemiological surveillance B. Active surveillance

These CC review the authority and capability of the VS to determine, verify and report on the sanitary status of the animal populations, including wildlife, under their mandate. The CC consider inter alia: - The list of notifiable diseases; - Contacts in other agencies on relevant areas (e.g. food safety; zoonoses, emerging diseases, wildlife) and procedures for sharing relevant surveillance information; - Knowledge of OIE standard on surveillance, including reporting duties and procedures on suspicions and confirmed cases. II-1. Veterinary laboratory diagnosis A. Access to veterinary laboratory diagnosisThis CC reviews the authority and capability of the VS to identify and record pathogenic agents, including those relevant for public health, that can adversely affect animals and animal products, and the suitability, effectiveness and efficiency of the national (public and private) laboratory infrastructures to service the needs of the VS. These CC consider inter alia: - The list of notifiable and reportable diseases, present in the country, present in the region or that could enter the country, including emerging diseases, for which the access to laboratory diagnostic is lacking; - The list of foreign laboratories providing access to diagnostic work; - The access to human health laboratory services when needed , and agreement on diagnostic methods and procedures including for an emerging event/new pathogens) in animals and humans; - The formal links between laboratories and the laboratory network structure organogram, including the existence of a shared database system.

PREVENT 4: ZOONOTIC DISEA SES This technical ar ea focuses on beha viours, policies and/or practices that minimize the spill ov er , spr ead, and full emergence of zoonotic disease into or out of human populations prior to the de velopment of efficient human-to-human transmission. Countries should de velop and implement operational frame w orks that specify the actions necessar y to pr omote One Health a ppr oaches to policies, practices and beha viours that could minimize the risk of zoonotic disease emergence and spr ead.

PV s critical competency (cc) Description

IV-6. TransparencyThis CC reviews the authority and capability of the VS to notify the OIE of its sanitary status and other relevant matters (and to notify the WTO SPS Committee where applicable), in accordance with established procedures. The CC considers inter alia: - Procedures and organised mechanism for notifications to OIE and other relevant international organisations; - Knowledge of duties and obligations of membership. II-3. Risk analysisThis CC reviews the authority and capability of the VS to base its risk management decisions on risk assessment. The CC considers inter alia: - Database of epidemiological data and of hazards relevant to animal health; - Database and procedures or tools used for risk analyses.

PV s critical competency (cc) Description

I-1. Professional and technical staffing of the Veterinary Services A - Veterinary and other professionals13 (university qualification) B - Veterinary para-professionals and other technical personnel

This CC reviews the appropriate staffing of the VS to allow for veterinary and technical functions to be undertaken efficiently and effectively. The CC reviews inter alia: - The approach for defining job descriptions, qualifications, experiences and formal appointment procedures; - The procedures for performance assessment and management; - The procedures for supervision of technical staff. I-2. Competencies of veterinarians and veterinary para-professionals A - Professional competencies of vete- rinarians including the OIE Day 1 competencies13 B - Competencies of veterinary para-professionals This CC reviews the capability of the VS to efficiently carry out their veterinary and technical functions, measured by the qualifications of their personnel in veterinary and technical positions. The CC reviews inter alia: - The curriculum of veterinary faculties, including education on public health and One health issues; - The curriculum of courses for veterinary para-professionals, and description of specialist qualifications and competencies.

In DIC aT ors In TH e J ee T - P re Ven T 4: Z oono TIC DI seases

P.4.2 Veterinary or Animal Health Workforce Key areas considered in this indicator: - The distribution of veterinary forces over the territory and at the different administrative levels; - The training programmes focusing zoonotic diseases The review of veterinary or animal health workforce should consider the veterinary framework both in terms of number of staff11 and qualifications12. Appropriate staffing of the VS allows technical functions to be undertaken efficiently and effectively. The majority of veterinary and other professional positions should be occupied by appropriately qualified personnel at central, state / provincial and local (field) levels. Main issues to consider here: i) allocation of appropriate number of qualified staff (veterinarian and para-veterinarian) to cover all the territory and all the key functions, with adequate capacity for the detection, assess- ment and response to unusual events;. ii) initial and continuing education of staff through training programmes adapted to the needs for adequate implementation of the IHR (2005). 11 - For the purposes of the Terrestrial Code and the OIE PVS Tool Veterinary Services means the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the Terrestrial Code and the OIE Aquatic Animal Health Code in the territory. In this context, this Critical Competence covers both the public and the private Veterinary para-professionals and other technical personnel. 12 - Reference in the Terrestrial Code of OIE, Article 3.2.5.1.: The Veterinary Services should demonstrate that their human resource component includes an integral core of full-time civil service employees. This core should always include veterinarians. It should also include administrative officials and veterinary para-professionals. The human resources may also include part-time and private sector veterinarians and veterinary para-professionals. It is essential that all the above categories of personnel be subject to legal disciplinary provisions. Data relating to the resource base of the Veterinary Services undergoing evaluation should be available 13 - Veterinary para-professional means a person who, for the purposes of the Terrestrial Code, is authorised by the veterinary statutory body to carry out certain designated tasks in a territory, and delegated to them under the responsibility and direction of a veterinarian. The tasks for each category of veterinary para-professional should be defined by the veterinary statutory body depending on qualifications and training, and according to need. 14 - In 2012 the OIE published Recommendations on the Competencies of graduating veterinarians (‘Day 1 graduates’) to assure the quality of national Veterinary Services at the entry-level. These recommendations are relevant to all Member Countries, regardless of the prevailing societal, economic and political circumstances. The document can be found at the OIE Website at http://www.oie.int/en/support-to-oie-members/veterinary-education/.

PV s critical competency (cc) Description

I-3. Continuing educationThis CC reviews the capability of the VS to maintain and improve the competence of their personnel in terms of relevant information and understanding; measured in terms of the implementation of a relevant training. The CC reviews inter alia: - Existing training programmes for relevant staff and procedures for continuing education linked to functions or positions; including on trans-sectoral thematic and One Health topics; - Evidence of interaction and collaboration between the Veterinary Authority and professional organisations, existence of continuing professional development programmes for private veterinarians, veterinary paraprofessionals, and other professionals.

In DIC aT ors In TH e J ee T - P re Ven T 4: Z oono TIC DI seases

P.4.3 Mechanisms for responding to infectious zoonoses and potential zoonoses are established and functional Key areas considered in this indicator: - The national policy, strategy or plans for a coordinated response to zoonotic events; - Timely exchange of information between sectors during zoonotic events; - The contingency plans, which include definition of roles and responsibilities Mechanisms are required to facilitate the coordination and management of outbreak operations in response to zoonotic events. Multidisciplinary/multisectoral Rapid Response Teams should have a good knowledge of procedures to rapidly, and in a coordinated manner, respond to zoonotic events.

PV s critical competency (cc) Description

II-6. Emergency responseThis CC reviews the authority and capability of the VS to response rapidly to a sanitary emergency (such as a significant disease outbreak or a food safety emergency). The CC reviews inter alia: - Network of human and physical resources available for emergency response; - Documented national contingency plans; - Evidence of simulation exercises and pre-established procedures. I-8. Operational fundingThis CC reviews the ability of the VS to access financial resources adequate for their continued and expanded operations (i.e. disease surveillance, early detection and rapid response, and veterinary public health), independent of political pressure. I-9. Emergency fundingThis CC reviews the capability of the VS to access extraordinary financial resources in order to respond to emergency situations or emerging issues. The CC reviews inter alia: - Approval process for additional resources and financial arrangements.

In DIC aT ors In TH e J ee T - P re Ven T 5: foo D safe Ty

P.5.1 Mechanisms are established and functioning for detecting and responding to foodborne disease and food contamination. Key areas considered in this indicator: - Focal points in relevant stakeholder groups and mechanisms for communication; - Coordination between surveillance, diagnostics, response; - Mechanism for rapid exchange of information during foodborne disease event. The role of the Veterinary Services has traditionally extended from the farm to the slaughterhouse, where veterinarians have a dual responsibility – epidemiological surveillance of animal diseases and ensuring the safety and quality of meat. The education and training of veterinarians, which includes food hygiene components, makes them uniquely equipped to play a central role in ensuring food safety, especially the safety of foods of animal origin. Control at import is also important. In addition to veterinarians, several other professional groups are involved in supporting integrated food safety approaches throughout the food chain. In many countries the role of the Veterinary Services has been extended to include subsequent stages of the food chain in the “farm to fork” continuum.

PREVENT 5: FOOD S AFETY States Par ties should ha ve sur veillance and response ca pacity f or food borne disease risks and ev ents. Ther e ar e often man y actors in volv ed and this r equir es eff ectiv e intersectoral comm unication and collaboration. PV s critical competency (cc) Description

II-8. Food safety B. - Ante and post mortem inspection at abattoirs and associated premises (e.g. meat boning/cutting establishments and rendering plants)

This CC reviews the authority and capability of the VS to implement and manage the inspection of animals destined for slaughter at abattoirs and associated premises, inclu- ding for assuring meat hygiene and for the collection of information relevant to livestock diseases and zoonoses. The CC reviews inter alia: - The collection of information relevant to livestock diseases, foodborne disease and zoonoses; - Evidence of coordination between PH and VS regarding the occurrence of human foodborne illness and potential linkages to food of animal origin, including actions of the VS. II-8. Food safety B - Ante and post mortem inspection at abattoirs and associated premises

This CC reviews the authority and capability of the VS to implement and manage the inspection of animals destined for slaughter at abattoirs and associated premises, inclu- ding for assuring meat hygiene and for the collection of information relevant to livestock diseases and zoonoses. The CC reviews inter alia: - The legislative framework and documented chain of command - Procedures for inspection, including the collection and analysis of relevant samples. - The collection of information relevant to livestock diseases, foodborne disease and zoonoses; - Evidence of coordination between PH and VS regarding the occurrence of human foodborne illness and potential linkages to food of animal origin, including actions of the VS. II-8. Food Safety C. Inspection for collection, proces- sing and distribution of products of animal origin

This CC reviews the authority and capability of the VS to implement, manage and coordinate food safety measures on collection, processing and distribution of products of animal, including programmes for the prevention of specific food-borne zoonoses and general food safety programmes. The CC reviews inter alia: -The roles and responsibilities of competent authorities (national VS, specific agency or department, Ministry of Health, local government or administration, private sector, etc.); -The procedures followed by personnel, including for the collection and analysis of relevant samples; -The coordination between relevant competent authorities regarding the occurrence of human foodborne illness and potential linkages to food of animal origin. II-6. Emergency responseThis CC reviews the authority and capability of the VS to respond rapidly to a sanitary emergency (such as a significant disease outbreak or food safety emergency). The CC reviews inter alia: - Physical and financial resources, available for emergency response; - Procedures and roles and responsibilities at all levels and functions for emergency response.

PV s critical competency (cc) Description

II-4 Quarantine and border securityThis CC reviews the authority and capability of the VS to prevent the entry and spread of diseases and other hazards of animals and animal products. The CC reviews inter alia: - Reports or information on imports of animals or products of animal origin (types, quantities, provenance, etc.); - Up-to-date information and agreement on cooperation with neighbours/trading partners’ on issues affecting disease status; responsible staff and procedures. II-12. Identification and traceability. B - Identification and traceability of animal products This CC reviews the authority and capability of the VS, normally in collaboration with producers and other interested parties to identify and trace products of animal origin for the purpose of food safety animal health or trade. The CC reviews inter alia: - Tracing procedures and databases - List of identified and traced food products of animal origin

In DIC aT ors In TH e J ee T - P re Ven T 6: bI osafe Ty an D bI ose CU rIT y

P.6.1 Whole-of-government biosafety and biosecurity system is in place for human, animal, and agriculture facilities Key areas considered in this indicator: Biosafety and biosecurity legislation and regulation; - Biological risk management training; - Inventory of strain collections; - Licensing containment laboratories; - Oversight monitoring mechanisms and enforcement activities Veterinary diagnostic laboratories receive samples on a routine basis for many contagious diseases, including zoonotic diseases. Laboratories that handle dangerous pathogens must have special requirements for the protection of the personnel who work with the pathogens, and protection of the environment and the public at large from contamination that could result from release of pathogens from the laboratory. Vete- rinary laboratories are under same obligation as human laboratories to exercise adequate biosafety and biosecurity measures.

In DIC aT ors In TH e J ee T - P re Ven T 6: bI osafe Ty an D bI ose CU rIT y

P.6.2 Biosafety and biosecurity training and practices Key areas considered in this indicator: - Training needs; - Exercises on biosecurity measures; - Training on the transport of infectious substance. Veterinary diagnostic laboratories receive samples on a routine basis for many contagious diseases, including zoonotic diseases. Laboratories that handle dangerous pathogens must have special requirements for the protection of the personnel who work with the pathogens, and protection of the environment and the public at large from contamination that could result from release of pathogens from the laboratory. Vete- rinary laboratories are under same obligation as human laboratories to exercise adequate biosafety and biosecurity measures.

PREVENT 6: BIOS AFETY AND BIOSECURITY This technical ar ea r ef ers to the whole-of-g ov ernment national biosaf ety and biosecurity system, ensuring the saf e and secur e use , storage , disposal, containment and monitoring of danger ous patho gens. Educational outr each and specific biological risk management trainings pr omote a shar ed cultur e of responsibility and reduce risks in all r ele vant sectors. PV s critical competency (cc) Description

II-1. Veterinary laboratory diagnosis B. Suitability of national laboratory infrastructures

This CC reviews the suitability, effectiveness and efficiency of the national (public and private) laboratory infrastructures to service the needs of the VS. The CC considers inter alia: - The organisation, management and financing of laboratory infrastructure. II-2. Laboratory quality assuranceThis CC reviews the quality of laboratories (that conduct diagnostic testing or analysis for chemical residues, antimicrobial residues, toxins, or tests for, biological efficacy, etc.) as measured by the use of formal Quality Assurance (QA) systems and participation in relevant proficiency testing programmes. The CC considers inter alia: - The QA systems used (including standard operating procedures, testing manuals, records of results); - The procedures for audit and updating of sampling, submission and laboratory analytical procedures - The procedures for national authorisation / accreditation of laboratories; The list of authorised / accredited laboratories II-9. Veterinary medicines and biologicalsThis CC reviews the authority and capability of the VS to regulate veterinary medicines and veterinary biologicals in order to ensure their responsible and prudent use i.e. the marketing, authorisation , registration, import, manufacture, quality control, export, labelling, advertising, distribution, sale and use of these products. The CC considers inter alia: - The list of medicines and biological products authorised and registered, - Inspections and procedures.

PV s critical competency (cc) Description

II-1. Veterinary laboratory diagnosis A. Access to veterinary laboratory diagnosisThis CC reviews the authority and capability of the VS to have access to laboratory diagnosis in order to identify and record pathogenic agents, including those relevant for public health, that can adversely affect animals and animal products. The CC considers inter alia: Lists and knowledge - Physical, human (including competencies and continuing education) and financial resources of laboratories; - Knowledge of procedures for sample collection and submission to an OIE Reference Laboratory II-2. Laboratory quality assurance.This CC reviews the quality of laboratories (that conduct diagnostic testing or analysis for chemical residues, antimicrobial residues, toxins, or tests for, biological efficacy, etc.) as measured by the use of formal Quality Assessment systems and participation in relevant proficiency testing programmes. The CC considers inter alia: - Job description including QA; - Relevant QA training. I-2.Competencies of veterinarians and veterinary para-professionals A - Professional competencies of vete- rinarians including the OIE Day 1 competencies15

This CC reviews the capability of the VS to efficiently carry out their veterinary and technical functions, measured by the qualifications of their personnel in veterinary and technical positions. The CC considersinter alia: - The curriculum of veterinary faculties. I-3. Continuing educationThis CC reviews the capability of the VS to maintain and improve the competence of their personnel in terms of relevant information and understanding; measured in terms of the implementation of a relevant training. The CC considers inter alia: - Existing training programmes for relevant staff and procedures for continuing education linked to functions or positions; - Existence of continuing professional development programmes for private veterinarians. 15 - In 2012 the OIE published Recommendations on the Competencies of graduating veterinarians (‘Day 1 graduates’) to assure the quality of national Veterinary Services at the entry-level. These recommendations are relevant to all Member Countries, regardless of the prevailing societal, economic and political circumstances. The document can be found at the OIE Website at http://www.oie.int/en/support-to-oie-members/veterinary-education/.

PREVENT 7: IMMUNIZA TION Ther e is no clear r ef er ence to this technical ar ea in the OIE PVS tools